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Clinical Trial Regulations With ICH GCP E6 R2 Workshop

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Clinical Trial Regulations With ICH GCP E6 R2 Workshop

Complexity and cost of clinical trials have increased dramatically in recent years. Learn how evolutions in technology and risk management process offer new opportunities to increase efficiency and focus on relevant activities. Understand how the new guidelines and regulations allow taking strategic decisions that benefit your organization’s success.

Target Industry: From large to small Pharmaceutical companies, Biotech, Medical Devices, Clinical Research Organization and Academic Research Organizations.


By attending this course, participants will:

  • Benefit from more efficient approaches on clinical development while continuing to ensure human subject protection and data      integrity.
  • Become familiar with the new clinical research process such as risk quality management systems.
  • Understand the drivers of risk-based monitoring planning and implementation.
  • Know how to align sponsor responsibilities with clinical research organizations duties, by a synergistic collaboration of several      functions with a variety of external stakeholders.
  • Learn why and how new clinical trials guidelines and regulations contribute to success in an environment that changed dramatically      due to new technologies.
  • Be armed with a box full of tools and case studies you can use back in the office.

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